Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA

Официальное название

Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial

Обзор

Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Подробное описание

Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.

1. Informed consent from participating children's parents. 2. Baseline records photographs, percussion test, periapical radiograph and personal data collection. 3. Diagnostic chart with personal, medical and dental history will be filled. 4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion). 5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination). 6. Preoperative and Postoperative photographs will be taken.

Вмешательства

• Процедура Partial Pulpotomy
  After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
• Процедура Complete pulpotomy
  After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

Первичные конечные точки

• Postoperative pain [Срок оценки: one week postoperative]
• Swelling/ Fistula [Срок оценки: 3, 6, 9, 12 months]
• Mobility [Срок оценки: 3, 6, 9, 12 months]

Вторичные конечные точки (1)

• Radiographic success [Срок оценки: 0, 6, 12 months]

Критерии участия

Критерии включения

• Patients:

• Aged 4-7 years, in good general health and medically within normal.

Teeth:

• Restorable mandibular second primary molars.
• History of reversible pulpitis.

Preoperative radiograph:

• Absence of periapical or inter-radicular radiolucency.
• Absence of widening of periodontal ligaments (PDL) space.
• Absence of internal or external root resorption.

Критерии исключения

• Patients:

• With systemic disorders.
• Physical or mental disabilities.
• Unable to attend follow-up visits.
• Refusal of Participation.
• Refusal to sign the informed consent.

Teeth:

• Previously accessed teeth.
• Mobile mandibular second primary molar.
• Swelling in the vestibule or on palpation.
• Pain on percussion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06524076 · 28052024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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